A Study of DLX105-DMP in Subjects With Plaque Psoriasis

NCT04203433 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DLX105-DMP-201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (5)

• Local Tolerability Sensations

  4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe

  Up to 4 Weeks

• Local Site Application Assessment

  Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles

  Up to 4 Weeks

• Adverse Events

  Treatment Emergent Adverse Events

  Day 1 through End of Study (Up to 4 Weeks after Last Dose)

• Local Investigator Global Assessment (IGA)

  Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe

  Day 1 through End of Study (Up to 4 Weeks after Last Dose)

• Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)

  Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.

  Day 1 through End of Study (Up to 4 Weeks after Last Dose)

Secondary Outcomes (2)

• Pharmacokinetic Parameters

  Day 1, Day 15, and Day 25

• Immunogenicity Testing

  Up to 4 Weeks after Last Dose

Study Arms (2)

DLX105-DMP Multi-Dose Twice Weekly

EXPERIMENTAL

4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly

Drug: DLX105-DMP

DLX105-DMP Multi-Dose Once Weekly

EXPERIMENTAL

4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly

Drug: DLX105-DMP

Interventions

DLX105-DMP DRUG

1mg applied to target lesion

DLX105-DMP Multi-Dose Once Weekly; DLX105-DMP Multi-Dose Twice Weekly

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent.
• Subjects aged 18-75 years.
• Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.
• Stable chronic mild-to-moderate plaque psoriasis.

You may not qualify if:

• Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.
• Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1.
• Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1

Sponsors & Collaborators

• DelArrivo, Inc.: lead

Study Sites (4)

DelArrivo Investigational Site

Alpharetta, Georgia, 30022, United States

Location

DelArrivo Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

DelArrivo Investigational Site

San Antonio, Texas, 78229, United States

Location

DelArrivo Investigational Site

Norfolk, Virginia, 23502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: March 21, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)